BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1000113 · Received February 19, 2008

    Report

    Report Number
    6000030-2008-00794
    Event Type
    Injury
    Date Received
    February 19, 2008
    Date of Event
    November 1, 2007
    Report Date
    February 11, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS ADMITTED TO THE HOSPITAL WITH INCREASED SPASTICITY. THROUGHOUT NOVEMBER & DECEMBER, THE PT'S DOSE SLOWLY INCREASED FROM 900 MCG/ML TO 1100 MCG/ML; ALL WITHOUT ANY PT IMPROVEMENT. THE DOSE WAS THEN DECREASED TO 1050 MCG/ML AND A FEW DAYS LATER, THE PT CAME IN WITH UNSPECIFIED SIGNS OF AN OVERDOSE. THE PUMP WAS REPROGRAMMED TO ITS MINIMUM RATE AND THE PT RECOVERED; HOWEVER, 16 MLS WAS ASPIRATED FROM THE RESERVOIR WHEN THE EXPECTED RESERVOIR VOLUME WAS 3 MLS. THE PUMP WAS REFILLED AND REPROGRAMMED AT THAT TIME. THEN AT THE LAST REFILL, THEY FOUND THE ENTIRE 18 MLS LEFT IN THE RESERVOIR. THE PUMP WAS REPLACED. IT WAS REPORTED THAT POST REPLACEMENT, THE THERAPY WAS WORKING AND THE PT WAS DOING FINE AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8626 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R